As I look back on 2023, the frustration and concern on behalf of the biosimilar industry is inescapable. For adalimumab biosimilar manufacturers, it was a lost year. Period.
The adalimumab market represents the greatest opportunity for biosimilar makers since the approval of Zarxio®, the first biosimilar approved in the United States. It is certainly the greatest opportunity in terms of monetary savings for the US health system (and may prove to be the GOAT based on savings potential). And save money we did: to the tune of 35% to 40%; we’ll need to wait for the fourth-quarter earnings report to confirm exactly how much.
For AbbVie, maker of the reference product Humira®, sales of the brand and retention of its marketshare have turned out better than they could have hoped. As we reported in 2023, AbbVie executives were expecting low single-digit loss of share by the end of the year, but a 38% drop in net revenues (which is attributable to significantly increased rebates).
They could not have dreamed that they would lose only 1% of prescriptions over nearly the entire year, according to IQVIA data shared graciously with BR&R. In November 2023, the total number of adalimumab prescriptions written in the US was 848,047. The total prescriptions filled with biosimilars was a paltry 8,726. Do the math. In 2023, payers and PBMs largely grabbed the increased rebates (not lower WAC price offerings) provided by AbbVie to hold off competition.
The only (meager) positive for the 9 adalimumab biosimilar makers is that the number of biosimilar prescriptions have been increasing each month since July (starting at 3,098), when the bulk of competitors entered the market.
When Amgen launches its high-concentration formulation of Amjevita®, presumably this month, the market will have the first interchangeable adalimumab in the most commonly used concentration. Will this move the needle in 2024, along with other anticipated launches through the second quarter? Based on the very low uptake of the first low-concentration, interchangeable (Cyltezo®), the best thing I can say is, “it couldn’t hurt.” Automatic substitution has not been a game-changer for any biosimilar to date.
Furthermore, when AbbVie launches its unbranded version of Humira, at a competitive low-WAC price, the biosimilar makers may find it more difficult to gain ground.
Still, there are some reports of progress. First, the news last week that CVS Caremark will exclude Humira from its major formularies on April 1. Sandoz may be the biggest beneficiary, as CVS works with the biosimilar maker through Cordavis to produce yet another product based on Sandoz’s Hyrimoz®. However, if it also decides to cover AbbVie’s co-branded product with Cordavis, that would negate any progress here. AbbVie’s offering will not offer any additional savings over the biosimilar competition and will support a company that has made more than $100 billion from the product already (in the US alone).
Congress has ramped up public pressure on PBMs to increase their transparency, which may force a move away from rebates over time. Blue Shield of California’s 2023 announcement of its shift from the traditional PBM contracting model may also be a harbinger of change. That change cannot come soon enough for biosimilars of other products covered under the pharmacy benefit, like ustekinumab, which will be launched next January.
It may take moves by important government players, like the Department of Veterans Affairs or the Centers for Medicare and Medicaid Services, to more aggressively support adalimumab biosimilars, because we know that the commercial payers and PBMs will not do it.
The biosimilar industry has been put into an extraordinarily difficult position. Without uptake of their products in the most costly drug categories, where they are priced very competitively, they will cease to develop biosimilars. And without biosimilar competition, forget cost savings on these originator biologics—instead, you’ll see annual price hikes, lower value, and greater access restrictions.